Clinical Trials Register

Summary
EudraCT Number:	2019-003186-18
Sponsor's Protocol Code Number:	LOWOL-19
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-12-02
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2019-003186-18

A.3

Full title of the trial

EFICACY AND TOLERABILITY OF TWO REDUCED VOLUME PRODUCTS FOR COLORRECTAL CANCER SCREENING COLONOSCOPY: A COMPARATIVE, PARALLEL RANDOMIZED CLINICAL TRIAL. LOWOL STUDY.

EFICACIA Y TOLERABILIDAD DE DOS PRODUCTOS DE VOLUMEN REDUCIDO PARA LA COLONOSCOPIA DE CRIBADO DE CÁNCER COLORRECTAL: ENSAYO COMPARATIVO PARALELO ALEATORIZADO. LOWOL Study.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

EFICACY AND TOLERABILITY OF TWO REDUCED VOLUME PRODUCTS FOR COLORRECTAL CANCER SCREENING COLONOSCOPY: A COMPARATIVE, PARALLEL RANDOMIZED CLINICAL TRIAL. LOWOL STUDY.

EFICACIA Y TOLERABILIDAD DE DOS PRODUCTOS DE VOLUMEN REDUCIDO PARA LA COLONOSCOPIA DE CRIBADO DE CÁNCER COLORRECTAL: ENSAYO COMPARATIVO PARALELO ALEATORIZADO. LOWOL Study.

A.3.2

Name or abbreviated title of the trial where available

LOWOL-19

A.4.1

Sponsor's protocol code number

LOWOL-19

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Fundació Clínic per a la Recerca Biomèdica
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Fundació Clínic per a la Recerca Biomèdica
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CTU CLINIC
B.5.2	Functional name of contact point	Joan Albert Arnaiz
B.5.3	Address:
B.5.3.1	Street Address	C. Villarroel, 170
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08036
B.5.3.4	Country	Spain
B.5.4	Telephone number	34932279838
B.5.5	Fax number	34932279877
B.5.6	E-mail	jaarnaiz@clinic.cat

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Pleinvue®
D.2.1.1.2	Name of the Marketing Authorisation holder	Norgine BV
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for oral solution in sachet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	macrogol
D.3.9.1	CAS number	25322-68-3
D.3.9.3	Other descriptive name	MACROGOL 3350
D.3.9.4	EV Substance Code	SUB20628
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Citrafleet
D.2.1.1.2	Name of the Marketing Authorisation holder	Casen Recordati, S.L.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for oral solution in sachet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	citric acid
D.3.9.1	CAS number	77-92-9
D.3.9.3	Other descriptive name	CITRIC ACID ANHYDROUS
D.3.9.4	EV Substance Code	SUB29050
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10.97
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

compare the adenoma detection rate between the two products

Comparar la tasa de detección de adenomas entre amabos productos

E.1.1.1

Medical condition in easily understood language

how many benign tumors can be detected with each product

cuántos tumores benignos pueden detectarse con cada producto

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Compare the clinical efficacy between two products in individuals who will undergo a colonoscopy in a CCR screening program.

Comparar la eficacia clínica entre dos productos en individuos que se someterán a una colonoscopia en un programa de cribado de CCR.

E.2.2

Secondary objectives of the trial

- Compare the Injury Detection Rate (TDL) between both medications.
- Compare the quality of colonic cleaning (Boston classification)
- Compare tolerability and satisfaction
- Compare the rates of adverse effects
- Evaluate the factors associated with the quality of the preparation between both medications
- Evaluate the correlation between colonic cleaning quality and clinical efficacy in global and in each product
- Evaluate the factors associated with the tolerability of both medications
- Evaluate the factors associated with the satisfaction of both medications
- Evaluate the factors associated with the occurrence of adverse effects in both medications.
- Compare the pregnancy survival curve between the Study and the Placebo Group.

- Comparar la Tasa de Detección de Lesiones (TDL) entre ambos medicamentos.
- Comparar la calidad de la limpieza colónica (clasificación de Boston)
- Comparar la tolerabilidad y satisfacción
- Comparar la tasas de efectos adversos
- Evaluar los factores asociados a la calidad de la preparación entre ambos medicamentos
- Evaluar la correlación entre calidad de limpieza colónica y eficacia clínica en global y en cada producto
- Evaluar los factores asociados a la tolerabilidad de ambos medicamentos
- Evaluar los factores asociados a la satisfacción de ambos medicamentos
- Evaluar los factores asociados a la aparición de efectos adversos en ambos medicamentos.
- Comparar la curva de supervivencia de la gestación entre el Estudio y el Grupo Placebo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Men and women 50 to 69 years old
2) Have participated in the Program for early detection of colon and rectal cancer
3) Positive result in the fecal occult blood test (≥20 μg Hb / g feces)
4) Have scheduled screening colonoscopy at the Hospital Clínic de Barcelona
5) Have signed the informed consent.

1) Hombres y mujeres de 50 a 69 años
2) Haber participado en el Programa de detección precoz de cáncer de colon y recto
3) Resultado positivo en el test de sangre oculta en heces (≥20 μg Hb/g heces)
4) Tener programada colonoscopia de cribado en el Hospital Clínic de Barcelona
5) Haber firmado el consentimiento informado.

E.4

Principal exclusion criteria

1) People affected by known severe renal impairment (grade IV or V) and congestive heart failure (class III and IV according to the New York Heart Association Scale)
2) People who have performed a colonoscopy during the last year
3) People who meet the Rome IV Criteria for the diagnosis of functional constipation
4) Persons with mental disabilities or severe mental disorders (schizophrenia and other psychotic disorders, recurrent severe major depressive disorders, severe obsessive-compulsive disorder, severe personality disorders and bipolar disorders)
5) People who do not understand Catalan or oral and written Spanish
6) People with partial or total colon resection
7) People with a personal history of CRC or tributary colorectal pathology of a specific follow-up (ulcerative colitis, Crohn's disease or colorectal adenomas)
8) People with terminal illness or serious illness / disability that contraindicates the subsequent study of the colon
9) Persons who do not sign the informed consent

1) Personas afectadas de insuficiencia renal grave (grado IV o V) conocida e insuficiencia cardíaca congestiva (clase III y IV según la Escala de la New York Heart Association)
2) Personas que hayan realizado una colonoscopia durante el último año
3) Personas que cumplan los Criterios de Roma IV para el diagnóstico de estreñimiento funcional
4) Personas con discapacidad mental o trastorno mental grave (esquizofrenia y otros trastornos psicóticos, trastornos depresivos mayores graves recurrentes, trastorno obsesivo-compulsivo grave, trastornos de la personalidad severos y trastornos bipolares)
5) Personas que no comprendan el catalán o el español oral y escrito
6) Personas con resección parcial o total del colon
7) Personas con antecedentes personales de CCR o patología colorrectal tributaria de un seguimiento específico (colitis ulcerosa, enfermedad de Crohn o adenomas colorrectales)
8) Personas con enfermedad terminal o enfermedad/invalidez grave que contraindique el estudio posterior del colon
9) Personas que no firmen el consentimiento informado

E.5 End points

E.5.1

Primary end point(s)

Adverse reaction to the product

reacción adversa al producto

E.5.1.1

Timepoint(s) of evaluation of this end point

Visit 1

E.5.2

Secondary end point(s)

None

Ninguna

E.5.2.1

Timepoint(s) of evaluation of this end point

None

Ninguno

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LV/LP

Última visita del último paciente

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

364

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

828

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Ninguno

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-02-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-01-17

P. End of Trial
P.	End of Trial Status	Completed

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